Contents Location About the job Benefits Things you need to know Apply and further information Location South Mimms, Hertfordshire About the job Job summary We are currently looking for a Senior Scientist and Cell Production Lead to join our Biotherapeutics & Advanced Therapies team in the Research & Development function within the Science, Research & Innovation group. This is a full-time opportunity, on a permanent basis. The role will be lab based in South Mimms, Hertfordshire. Please be aware that this role can only be worked in the UK and not overseas. Who are we? The Medicines and Healthcare products Regulatory Agency enhance and improve the health of millions of people every day through the effective regulation of medicines and medical devices, underpinned by science and research. The Science, Research & Innovation group delivers public health impact, world-leading research innovation, and a unique proposition via an ambitious Science Strategy which will balance innovation against sustainability and affordability. It is divided into 4 sub-Groups, Research and Development, Standards Lifecycle, Control Testing and Quality Assurance and Health & Safety. The Research & Development function deliver statutory mandated strategically aligned, sustainable and impactful Regulatory Scientific research that is applied primarily to biological reference materials development and medicines control testing and areas of international and national priority for extant and future biological medicines. R&D host and nurture the current excellence in research into biologicals, biological reference materials, biological activity measurements, product quality testing and standardisation that is currently hosted by the National Institute for Biological Standards and Control (NIBSC). This is a statutory activity and includes international centres of excellence such as those working on polio, influenza and the UK Stem Cell Bank. The Advanced Therapies Team in the R&D function comprises a multi-disciplinary team of internationally respected scientists whose focus is on the regulatory research required to ensure safe and effective Advanced Therapy medicines are available to patients. Job description Whats the role? The post holder shall provide scientific and technical input into the day-to-day banking, QC activities of the UKSCB and validation of equipment and processes. They will ensure that the work streams are completed to the agreed timelines and within the required quality framework. The work will be centered around the banking, characterisation and safety testing of human embryonic stem cells under the Human and Tissues Authority (HTA) for Human Use (Regulations 2007). The post-holder is also expected to deliver on internal and external cell supply under the ISO 9001 quality system and to Deputise for the Head of Cell Production. Key responsibilities: Ensure effective service delivery by carrying out banking and quality control testing of human embryonic stem cells according to UKSCB standard operating procedures and ensuring HTA compliance. Ensure effective delivery of cell production service under ISO9001, including banking, QC, stock control and supplying mammalian cells both globally and within the institute. Provide scientific and technical input into the banking programme including validation studies on processes and equipment. Write reports and represent the UKSCB at consortium and other meetings as appropriate. Deputise for the Head of Cell Production as required. Including, but not limited to: ensuring banks of cell lines are established according to documented procedures and specifications; Maintain Quality Systems operating in the Group (HTA and ISO 9001). Write, review and maintain quality records, including cell line documentation, qualification and validation reports, standard operating procedures, COSHH and risk assessments. Contribute to service delivery and improvement. Provide training in stem cell banking & QC procedures for staff, visiting workers and participants on UKSCB-run training courses. Monitor the effectiveness of UKSCB banking and identify areas of improvement and support implementation of new policies. Person specification Our successful candidate will meet the following criteria: BSc or MSc in cell or molecular biology, or a related discipline (or equivalent experience). Knowledge of working with under HTA (Human Application) and/or GMP. Extensive practical experience of pluripotent stem cell cultures and of other mammalian cell types. Extensive practical experience of molecular and cell biology, including microscopy, flow cytometry and qPCR. Delivering at Pace Excellent organisational skills and ability to plan work to optimise time management and output across multiple projects. If you would like to find out more about this fantastic opportunity, please read our Job Description and Person Specification Please note: The job description may not open in some internet browsers. Please use Chrome or Microsoft Edge. If you have any issue viewing the job description, please contact careersmhra.gov.uk Benefits Alongside your salary of £44,825, Medicines and Healthcare Products Regulatory Agency contributes £12,985 towards you being a member of the Civil Service Defined Benefit Pension scheme. Find out what benefits a Civil Service Pension provides. Annual Leave: 25 days annual leave on entry, rising by one day for each completed year of service to a maximum of 30 days and pro-rata for part-time staff. PLUS 8 bank holidays Privilege Leave: 1 day Hours of Work: 37 hours (net) per week for full time staff in all geographical locations, including London and pro rata for part-time staff Occupational Sick Pay (OSP): One month full pay/one month half pay on entry, rising by one month for each completed year of service to a maximum of five months full pay/five months half pay Mobility: Mobility clause in contracts allowing staff to be mobile across the Civil Service Civil Service Pension Scheme. Please see the link for further information http://www.civilservicepensionscheme.org.uk/ For enquiries relating to the Civil Service Pension Schemes please contact MyCSP's Pension Service Centre directly on 0300 123 6666 Flexible working to ensure staff maintain a healthy work-life balance Interest free season ticket loan or bike loan Employee Assistance Services and access to the Civil Service Benevolent Fund Eligibility to join the Civil Service Motoring Association (CSMA) Variety of staff and Civil Service clubs On-going learning and development Things you need to know Selection process details We use the Civil Service Success Profiles to assess our candidates, find out more here. Online application form, including questions that assess the Behaviour, Experience and Technical criteria on the person specification. Please ensure all application questions are completed in full; your application may not be considered if any responses are left blank. Our applications are CV blind, and our Hiring Managers will not be able to access your CV when reviewing your application. Please ensure not to include any personal identifying information on your supporting information. Presentation, to be prepared as part of your interview, with further information being supplied when you reach this stage. Interview, which can include questions based on the Behaviour, Experience, Technical and Strengths Success Profiles. Previous applicants need not apply. Applicants are assessed on whether they meet any mandatory requirements as well as the necessary skills and experience for the role. Applications are scored based on the answers provided. You can view the criteria for this role in the job description. In the instance that we receive a high number of applications, we will first sift against the lead criteria of Knowledge of working with under HTA (Human Application) and/or GMP. Use of AI in Job Applications Applicants must ensure that anything submitted is factually accurate and truthful. Plagiarism can include presenting the ideas and experience of others, or generated by artificial intelligence, as your own. If you require any disability related adjustments at any point during the process, please contact careersmhra.gov.uk as soon as possible. Closing date: 31 January 2025 Shortlisting date: 3 7 February 2025 Interview date: 17 21 February 2025 Candidates will be contacted within a week of the sift and the interviews completed to inform them of the outcome. If you need assistance applying for this role or have any other questions, please contact careersmhra.gov.uk Candidates will be subject to UK immigration requirements as well as Civil Service nationality rules. Further information on whether you are able to apply is available here. Successful candidates must pass a disclosure and barring security check as well as animal rights and pro-life activism checks. People working with government assets must complete basic personnel security standard checks. Applicants who are successful at interview will be, as part of pre-employment screening subject to a check on the Internal Fraud Database (IFD). This check will provide information about employees who have been dismissed for fraud or dishonesty offences. This check also applies to employees who resign or otherwise leave before being dismissed for fraud or dishonesty had their employment continued. Any applicants details held on the IFD will be refused employment. A candidate is not eligible to apply for a role within the Civil Service if the application is made within a 5 year period following a dismissal for carrying out internal fraud against government. Any move to the MHRA from another employer will mean you can no longer access childcare vouchers. This includes moves between government departments. You may however be eligible for other government schemes, including Tax-Free Childcare. Determine your eligibility here. Successful candidates may be subject to annual Occupational Health reviews dependent on role requirements. If you have any queries, please contact careersmhra.gov.uk. In accordance with the Civil Service Commissioners Recruitment Principles our recruitment and selection processes are underpinned by the requirement of selection for appointment on the basis of merit by a fair and open competition. If you feel your application has not been treated in accordance with the Recruitment Principles and you wish to make a complaint, you should firstly contact Mira Mepa, Head of Recruitment and Operations, Mira.Mepamhra.gov.uk. If you are not satisfied with the response you receive, you can contact the Civil Service Commission at: civilservicecommission.independent.gov.uk infocsc.gov.uk Civil Service Commission Room G/8 1 Horse Guards Road London SW1A 2HQ Feedback will only be provided if you attend an interview or assessment. Security Successful candidates must undergo a criminal record check. People working with government assets must complete baseline personnel security standard (opens in new window) checks. Nationality requirements This job is broadly open to the following groups: UK nationals nationals of the Republic of Ireland nationals of Commonwealth countries who have the right to work in the UK nationals of the EU, Switzerland, Norway, Iceland or Liechtenstein and family members of those nationalities with settled or pre-settled status under the European Union Settlement Scheme (EUSS) (opens in a new window) nationals of the EU, Switzerland, Norway, Iceland or Liechtenstein and family members of those nationalities who have made a valid application for settled or pre-settled status under the European Union Settlement Scheme (EUSS) individuals with limited leave to remain or indefinite leave to remain who were eligible to apply for EUSS on or before 31 December 2020 Turkish nationals, and certain family members of Turkish nationals, who have accrued the right to work in the Civil Service Further information on nationality requirements (opens in a new window) Working for the Civil Service The Civil Service Code (opens in a new window) sets out the standards of behaviour expected of civil servants. We recruit by merit on the basis of fair and open competition, as outlined in the Civil Service Commission's recruitment principles (opens in a new window). The Civil Service embraces diversity and promotes equal opportunities. As such, we run a Disability Confident Scheme (DCS) for candidates with disabilities who meet the minimum selection criteria. The Civil Service also offers a Redeployment Interview Scheme to civil servants who are at risk of redundancy, and who meet the minimum requirements for the advertised vacancy. Diversity and Inclusion The Civil Service is committed to attract, retain and invest in talent wherever it is found. To learn more please see the Civil Service People Plan (opens in a new window) and the Civil Service Diversity and Inclusion Strategy (opens in a new window). Apply and further information Once this job has closed, the job advert will no longer be available. You may want to save a copy for your records. Contact point for applicants Job contact : Name : The Recruitment Team Email : careersmhra.gov.uk Recruitment team Email : careersmhra.gov.uk Further information In accordance with the Civil Service Commissioners Recruitment Principles our recruitment and selection processes are underpinned by the requirement of selection for appointment on the basis of merit by a fair and open competition. If you feel your application has not been treated in accordance with the Recruitment Principles and you wish to make a complaint, you should contact the Resourcing Team at Careersmhra.gov.uk, in the first instance. If you are not satisfied with the response you receive you can contact the Civil Service Commission at: civilservicecommission.independent.gov.uk - infocsc.gov.uk - Civil Service Commission Room G/8 1 Horse Guards Road London SW1A 2HQ Apply at advertiser's site Share this page Print Email Facebook Twitter LinkedIn GMail